Pipeline

Rapid-Acting, Ultra-ConcentratedFluorolog™ is a rapid-acting, ultra-concentrated (U-500) analog for the treatment of type 2 diabetes mellitus patients with high insulin resistance. Such patients, who must inject several hundred units of insulin each day to keep their blood sugar under control, are disproportionately members of underprivileged minority communities, including African-Americans, Hispanic Americans, and Indigenous Americans. Thermalin’s lead candidate, Fluorolog™, has performance characteristics similar to current, rapid-acting, meal-time U-100 analogs, such as Humalog® and Novolog®. Fluorolog™ is significantly more rapid-acting in both onset and post-meal duration than the only currently available ultra-concentrated analog, Humalin R U-500® from Lilly.

Expected Benefits:

Smaller, less painful injection volumes

Faster absorption

Could be taken close to meals

Reduced incidence and severity of late post-meal hypoglycemia and consequent snacking and weight gain

Ultra-Rapid-Acting AnalogsThermalin is utilizing both molecular and formulation strategies to produce an ultra-rapid-acting analog that has on-set and duration that are 30-50% faster than current rapid-acting analogs (e.g., Humalog and Novolog). Such a novel insulin would be better for meal-time administration and would greatly improve the performance of closed-loop, artificial pancreas pumps. “Smart,” closed-loop pumps determine insulin delivery from continuous glucose-sensor data; extended insulin absorption makes control algorithms inefficient and increases the risk of hypoglycemia. “Artificial pancreas” pumps have the potential to benefit everyone with type 1 diabetes mellitus, but especially patients whose history of poor compliance with detailed daily regimens leads to chronic hyperglycemia.

Ultra-Heat-﻿Stable ﻿AnalogsThermalin is developing ultra-heat-stable, long- and rapid-acting insulins for patients with limited access to refrigeration. Insulin that retains potency even after extended exposure to high ambient temperature would be useful in the developing world, the rural south, disaster areas and other areas with limited or reduced cold-chain distribution. Such ultra-stable insulins can also potentially enable an implantable, closed-loop pump, considered the best potential solution to diabetes mellitus short of a cure, because the insulin could withstand body temperature for months without degrading. Thermalin has already developed an intermediate-acting, ultra-stable insulin that has retained full potency after exposure to body temperature and agitation in an uncoated glass vial for more than one year.

Expected Benefits:

Stable for months in warm climates without refrigeration

Resistant to temperature spikes up to 115◦F

Suitable for distribution without cold-chain logistics

Enables pre-filled patch pump reservoirs

Enables implantable, closed-loop pumps

﻿Biphasic Analogs﻿Thermalin is developing insulin analogs which start working fast but which have a prolonged tail of action. This time-action-profile is analogous to that of currently marketed insulin premixes, which combine a rapid-acting insulin with an intermediate-acting NPH insulin. Premixes are utilized in situations where a simple, twice-a-day (breakfast and dinner) regimen is required. Premixes represent the majority of insulin sold in China.